(1) Except
as provided in division (A)(2) of this section, all newborn children shall be
screened for the presence of the genetic, endocrine, and metabolic disorders
specified in rules, adopted pursuant to this section.

(2) Division (A)(1) of this section does not apply
in either of
the following circumstances:

(a) If the parents of the child object
to the
screening on the grounds that it conflicts with their
religious tenets and practices;

(b) With respect to the screening for Krabbe disease described
in division (C)(1)(b) of this section, if the parents of the child communicate
their decision to forgo the screening.

(B) There is hereby created the newborn screening
advisory council to advise the director of health regarding the screening of
newborn children for genetic, endocrine, and metabolic disorders. The council
shall engage in an ongoing review of the newborn screening requirements
established under this section and shall provide recommendations and reports to
the director as the director requests and as the council considers necessary.
The director may assign other duties to the council, as the director considers
appropriate.

The council shall
consist of fourteen members appointed by the director. In making appointments,
the director shall select individuals and representatives of entities with
interest and expertise in newborn screening, including such individuals and
entities as health care professionals, hospitals, children's hospitals,
regional genetic centers, regional sickle cell centers, newborn screening
coordinators, and members of the public.

The department of
health shall provide meeting space, staff services, and other technical
assistance required by the council in carrying out its duties. Members of the
council shall serve without compensation, but shall be reimbursed for their
actual and necessary expenses incurred in attending meetings of the council or
performing assignments for the council.

The council is not
subject to sections 101.82 to
101.87 of the Revised
Code.

(a)Subject to division
(C)(1)(b) of this section, the director of health shall adopt rules in
accordance with Chapter 119. of the Revised Code specifying the disorders for
which each newborn child must be screened.

(b) In adopting the rules,
the director shall specify Krabbe disease as a disorder for which a newborn
child who is born on or after July 1, 2016, must be screened. The rules shall
limit the screening requirement for Krabbe disease to the process known as
"first tier testing," which is a screening for Krabbe disease that is
accomplished by measuring galactocerebrosidase activity using mass
spectrometry.

(2) The newborn screening advisory council shall
evaluate genetic, metabolic, and endocrine disorders to assist the director in
determining which disorders should be included in the screenings required under
this section. In determining whether a disorder should be included, the council
shall consider all of the following:

(d)
The expected benefits to children and society in relation to the risks and
costs associated with screening for the disorder;

(e)
Whether a screening for the disorder can be conducted without taking an
additional blood sample or specimen.

(3) Based on the considerations specified in division
(C)(2) of this section, the council shall make recommendations to the director
of health for the adoption of rules under division (C)(1) of this section. The
director shall promptly and thoroughly review each recommendation the council
submits.

(D) The director shall adopt rules in accordance with
Chapter 119. of the Revised Code establishing standards and procedures for the
screenings required by this section. The rules shall include standards and
procedures for all of the following:

(1)
Causing rescreenings to be performed when initial screenings have abnormal
results;

(2)
Designating the person or persons who will be responsible for causing
screenings and rescreenings to be performed;

(3)
Giving to the parents of a child notice of the required initial screening and
the possibility that rescreenings may be necessary;

(4)
Communicating to the parents of a child the results of the child's screening
and any rescreenings that are performed;

(5)
Giving notice of the results of an initial screening and any rescreenings to
the person who caused the child to be screened or rescreened, or to another
person or government entity when the person who caused the child to be screened
or rescreened cannot be contacted;

(6)
Referring children who receive abnormal screening or rescreening results to
providers of follow-up services, including the services made available through
funds disbursed under division (F) of this section.

(1) Except
as provided in divisions (E)(2) and (3) of this section, all newborn screenings
required by this section shall be performed by the public health laboratory
authorized under section
3701.22 of the Revised
Code.

(2) If the director determines that the public health
laboratory is unable to perform screenings for all of the disorders specified
in the rules adopted under division (C) of this section, the director shall
select another laboratory to perform the screenings. The director shall select
the laboratory by issuing a request for proposals. The director may accept
proposals submitted by laboratories located outside this state. At the
conclusion of the selection process, the director shall enter into a written
contract with the selected laboratory. If the director determines that the
laboratory is not complying with the terms of the contract, the director shall
immediately terminate the contract and another laboratory shall be selected and
contracted with in the same manner.

(3) Any rescreening caused to be performed pursuant to
this section may be performed by the public health laboratory or one or more
other laboratories designated by the director. Any laboratory the director
considers qualified to perform rescreenings may be designated, including a
laboratory located outside this state. If more than one laboratory is
designated, the person responsible for causing a rescreening to be performed is
also responsible for selecting the laboratory to be used.

(1) The
director shall adopt rules in accordance with Chapter 119. of the Revised Code
establishing a fee that shall be charged and collected in addition to or in
conjunction with any laboratory fee that is charged and collected for
performing the screenings required by this section. The fee, which shall be not
less than fourteen dollars, shall be disbursed as follows:

(a)
Not less than ten dollars and twenty-five cents shall be deposited in the state
treasury to the credit of the genetics services fund, which is hereby created.
Not less than seven dollars and twenty-five cents of each fee credited to the
genetics services fund shall be used to defray the costs of the programs
authorized by section
3701.502 of the Revised Code.
Not less than three dollars from each fee credited to the genetics services
fund shall be used to defray costs of phenylketonuria programs.

(b)
Not less than three dollars and seventy-five cents shall be deposited into the
state treasury to the credit of the sickle cell fund, which is hereby created.
Money credited to the sickle cell fund shall be used to defray costs of
programs authorized by section
3701.131 of the Revised
Code.

(2) In adopting rules under division (F)(1) of this
section, the director shall not establish a fee that differs according to
whether a screening is performed by the public health laboratory or by another
laboratory selected by the director pursuant to division (E)(2) of this
section.